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Completed

NCT Number: NCT04835051

Alive & Thrive Nigeria Breastfeeding Promotion in Urban Private Facilities Study

The purpose of this study was to evaluate the effect of a breastfeeding promotion intervention on breastfeeding intentions, early initiation of breastfeeding, and exclusive breastfeeding among clients in private health facilities in Lagos, Nigeria.

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Key information

Age range

15 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albina Majeed Clinic, Lagos, Nigeria

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About this study

This was a longitudinal cohort study designed to evaluate and measure the implementation processes of a breastfeeding counseling and support intervention offered to pregnant and postpartum women in private health facilities in Lagos State, Nigeria. This study was conducted as part of the Alive & Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design, implementation, and analysis for the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study took place in 20 private health facilities. Ten facilities were assigned to intervention and 10 to comparison based on their location within the existing intervention and comparison local government areas (LGAs) for our overall impact evaluation of the Alive & Thrive program in Nigeria (NCT02975063). To be included in the study, facilities had to provide maternity and pediatric services, such as antenatal care, postnatal care, and immunizations, and be registered with the Association of General and Private Medical Practitioners of Nigeria and the Health Facility Monitoring and Accreditation Agency. To ensure that the investigators would achieve their sample size, selected facilities with a monthly average of ≥40 antenatal clients and ≥20 deliveries over 3 months. All eligible women attending antenatal care on the days of data collection were invited to participate until the target enrollment at each facility was achieved. The investigators collected survey data from a cohort of 1,200 women (600 per study arm) during the third trimester of pregnancy and when their child was 6 weeks and 24 weeks. The purpose of the surveys were to obtain data on the women's breastfeeding intentions (third trimester) and practices (6 weeks and 24 weeks), their breastfeeding knowledge and attitudes, and their exposure to the intervention. To measure implementation outcomes, the investigators conducted 180 observations of client-provider interactions among a subset of women enrolled in the study and then completed a short exit interview with the women immediately after their facility visit. In addition, the investigators conducted qualitative interviews with 20 health providers and facility managers/owners in the intervention facilities at the end of the intervention to learn about the facilitators and barriers to implementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Women ≥18 years old, third trimester
  • Current Client of a private health facility
  • Infant alive at 6 and 24 weeks postpartum

Exclusion:

  • Infant died
  • Infant unable to breastfeed

Treatment and study plan

Breastfeeding promotion

Behavioral

The intervention included training of health workers in private health facilities to provide in-person breastfeeding counseling to pregnant women and women with a child <6 months during clinic visits. The health workers also offered a mobile phone support component for appointment reminders, breastfeeding SMS and WhatsApp messages, WhatsApp breastfeeding support groups, informational materials (posters and foldable pocket-sized cards), and family engagement activities. Breastfeeding-related mass media through television and radio spots was available state-wide, including to women in intervention and comparison facilities.

Primary outcomes

  1. Exclusive breastfeeding

    Time frame: 6 weeks

    The proportion of infants exclusively breastfed on the previous day

  2. Exclusive breastfeeding

    Time frame: 24 weeks

    The proportion of infants exclusively breastfed on the previous day

Secondary outcomes

  1. Early initiation of breastfeeding

    Time frame: At birth

    The proportion of infants who started breastfeeding within 1 hour of birth

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • FHI 360

Registry information

Official study title

Implementation Research on an Urban Private Sector Model of IYCF Counseling in Private Health Facilities in Lagos State

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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